BIO07026 2019 BIOCONTAMINATION CONTROL

General Details

Full Title
BIOCONTAMINATION CONTROL
Transcript Title
BIOCONTAMINATION CONTROL
Code
BIO07026
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Paul Walsh
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Science in Biopharmaceutical Science SG_SBIOE_E07 201900 Certificate in Science in Bioprocess Engineering L7
Description

This module aims to provide students with a fundamental knowledge and understanding of the general principles and methods of Biocontamination control; establishing and verifying the formal system for contamination control and associated test methods and requirements; traditional and modern methods of microbial detection; expressing, interpreting and reporting results; training and documentation requirements.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Discuss and evaluate the most relevant biocontamination organisms for the biopharmaceutical industry and the typical sources of each.

2.

Identify and discuss appropriate prevention techniques for each contaminant.

3.

Establish the theory behind the biocontamination detection test methods available, including traditional and rapid identification testing.

4.

Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.

5.

Perform some research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

6.

Communicate and explain scientific data relating to biocontamination control.

Teaching and Learning Strategies

N/A

Module Assessment Strategies

Continuous Assessment of Course Work - 50% of marks.

End of term written exam - 50% of marks.

 

Repeat Assessments

N/A

Indicative Syllabus

General principles and methods of Biocontamination control.

Basic microbiology and specific biocontamination organisms of relevance.

The formal system for biocontamination control and associated test methods and requirements.

Traditional and modern methods of microbial detection.

Potential sources of biocontamination.

Techniques & tools for prevention and correction/removal of biocontamination including, monitoring and detection methods.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Multiple Choice Questions Continuous Assessment Multiple Choice 15 % Week 6 1,2,3,4
2 Multiple Choice Questions Continuous Assessment Multiple Choice 15 % Week 11 1,2,3,4,5,6
3 LAQ Continuous Assessment Assessment 20 % Week 14 1,2,3,4,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 50 % End of Term 1,2,3,4
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Online 1 Weekly 1.00
Directed Learning Not Specified Course Notes / Slides 3 Weekly 3.00
Independent Learning UNKNOWN Mini Research Assignment 3 Weekly 3.00
Total Part Time Average Weekly Learner Contact Time 4.00 Hours

Module Resources

Non ISBN Literary Resources

Hugo and Russell's: Pharmaceutical Microbiology (Seventh Edition) Editor(s): Stephen P Denyer, Norman A Hodges, Sean P Gorman Print ISBN: 9780632064670 Online ISBN: 9780470988329.

Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition, 2nd Edition By Lucia Clontz. ISBN: 978-1-4200534-8-7.

Rapid Microbiological Methods in the Pharmaceutical Industry Editors: Martin C. Easter ISBN: 978-1-57491-141-1 (hardback) 978-0-203-01087-7 (electronic).

Journal Resources

N/A

URL Resources

N/A

Other Resources

None

Additional Information

None